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THE WOODLANDS, TX - Autonomix Medical, Inc. (NASDAQ: AMIX), a micro-cap medical device company valued at $4.04 million specializing in nervous system diseases, has announced the upcoming expansion of its clinical trial program to include a broader range of visceral cancers. The Ministry of Health of the Republic of Uzbekistan granted Autonomix Ethics Committee authorization to proceed with its follow-on phase, known as PoC 2, which focuses on evaluating the safety and efficacy of its proprietary ablation technology for cancer pain mitigation. According to InvestingPro analysis, the company maintains a healthy current ratio of 5.63, indicating strong short-term financial stability.
The company is poised to begin patient enrollment in June 2025, following promising results from its initial proof-of-concept trial targeting severe pancreatic cancer pain. The earlier study demonstrated significant pain reduction and improved quality of life for late-stage pancreatic cancer patients, alongside a substantial decrease in opioid use. InvestingPro data reveals the company is quickly burning through cash, with negative EBITDA of $11.4 million in the last twelve months, making financial execution crucial for future success.
Brad Hauser, CEO of Autonomix, stated that the approval to expand the trial marks a significant advancement for the company. He emphasized the potential of Autonomix’s technology to transform the standard of care across multiple cancer indications with high unmet needs.
The PoC 2 phase aims to evaluate the technology’s application in other visceral cancers that cause pain through the same neural pathways as pancreatic cancer, potentially doubling the addressable market. The technology holds promise for various indications beyond cancer pain, including cardiology and chronic pain management.
Autonomix’s catheter-based microchip sensing array platform is designed to detect and differentiate neural signals, offering a novel approach to transvascular diagnosis and treatment of peripheral nervous system diseases. However, it is important to note that the technology remains investigational and has not yet received marketing clearance in the United States.
The company’s forward-looking statements, including the timing of the PoC 2 phase commencement, involve risks and uncertainties. These statements are based on assumptions that may differ from actual future events or results. Investors should note that AMIX’s stock has declined by approximately 96% over the past year, trading at $1.64. Investors are advised to review cautionary statements and risk factors in the company’s filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K filed on May 31, 2024. For comprehensive financial analysis and additional insights, including 8 more exclusive ProTips, visit InvestingPro.
This news is based on a press release statement from Autonomix Medical, Inc.
In other recent news, Autonomix Medical, Inc. has announced the completion of its initial proof-of-concept trial phase, showcasing significant pain relief for late-stage pancreatic cancer patients. The trial demonstrated a 53.3% improvement in pain scores one week post-procedure, with 73% of patients remaining opioid-free at the 4-6 week follow-up. Following these promising results, Autonomix plans to expand the trial to include additional visceral cancers in 2025, potentially doubling its addressable market. The company has also secured a new European patent, expanding its portfolio to over 80 issued patents, which could support future applications in pain management. Autonomix is preparing for U.S. clinical studies in 2025, aiming for FDA approval by 2026. The company has enlisted medical experts in interventional radiology and cancer pain management to aid in this endeavor. CEO Brad Hauser expressed optimism about the technology’s potential to improve quality of life for patients with various visceral cancers. The company’s catheter-based microchip sensing array remains investigational and is not yet cleared for marketing in the U.S.
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